1

Regulatory Medical Writer Jobs (NOW HIRING)

Medical Writer / Clinical Document Author Role Type: Contractor Location: Remote micro1 is engaging ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

Medical Writer / Clinical Document Author Role Type: Contractor Location: Remote micro1 is engaging ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

Medical Writer / Clinical Document Author Role Type: Contractor Location: Remote micro1 is engaging ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

Medical Writer / Clinical Document Author Role Type: Contractor Location: Remote micro1 is engaging ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

Medical Writer / Clinical Document Author Role Type: Contractor Location: Remote micro1 is engaging ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

Medical Writer / Clinical Document Author Role Type: Contractor Location: Remote micro1 is engaging ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

Medical Writing Manager

Elgin, IL · Remote

$50 - $80/hr

Medical Writer / Clinical Document Author Role Type: Contractor Location: Remote micro1 is engaging ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

Medical Writer / Clinical Document Author Role Type: Contractor Location: Remote micro1 is engaging ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

Medical Writer / Clinical Document Author Role Type: Contractor Location: Remote micro1 is engaging ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

Medical Writer / Clinical Document Author Role Type: Contractor Location: Remote micro1 is engaging ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

Medical Writer / Clinical Document Author Role Type: Contractor Location: Remote micro1 is engaging ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

Medical Writer / Clinical Document Author Role Type: Contractor Location: Remote micro1 is engaging ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

Medical Writer / Clinical Document Author Role Type: Contractor Location: Remote micro1 is engaging ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

Medical Writer / Clinical Document Author Role Type: Contractor Location: Remote micro1 is engaging ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

Medical Writer / Clinical Document Author Role Type: Contractor Location: Remote micro1 is engaging ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

Medical Writer / Clinical Document Author Role Type: Contractor Location: Remote micro1 is engaging ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

Medical Writing Manager

Lowell, MA · Remote

$50 - $80/hr

Medical Writer / Clinical Document Author Role Type: Contractor Location: Remote micro1 is engaging ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

Showing results 41-60

Regulatory Medical Writer information

See salary details

$14

$38

$57

How much do regulatory medical writer jobs pay per hour?

As of Aug 8, 2026, the average hourly pay for regulatory medical writer in the United States is $38.64, according to ZipRecruiter salary data. Most workers in this role earn between $26.20 and $48.80 per hour, depending on experience, location, and employer.

How much does a regulatory medical writer make?

A regulatory medical writer typically earns between $70,000 and $130,000 annually, depending on experience, education, and location. Senior writers with specialized knowledge or certifications can earn higher salaries, especially in the pharmaceutical or biotech industries.

Is there a demand for regulatory medical writers?

Regulatory medical writers are in high demand due to the increasing need for clear, compliant documentation in the pharmaceutical, biotech, and healthcare industries. They often require knowledge of regulatory guidelines and proficiency with tools like document management systems, with job growth driven by ongoing drug development and approval processes.

What are the key skills and qualifications needed to thrive as a regulatory medical writer?

To thrive as a Regulatory Medical Writer, you need strong scientific knowledge, excellent written communication skills, and a degree in life sciences or a related field. Proficiency with regulatory documentation formats (such as CTD/eCTD), familiarity with guidelines like ICH, and experience using document management systems are often required. Meticulous attention to detail, organizational skills, and the ability to collaborate effectively with cross-functional teams are valuable soft skills. These qualifications are crucial to ensure the accurate, compliant, and timely preparation of regulatory submissions supporting drug approvals and clinical research.

What are some typical challenges faced by regulatory medical writers in their daily work?

Regulatory Medical Writers often face tight deadlines and shifting project priorities, especially when coordinating documents needed for regulatory submissions. They must interpret complex scientific data and adhere strictly to changing regulatory guidelines, which can be demanding. Navigating feedback from multiple stakeholders—such as clinical, regulatory, and statistical teams—requires strong communication and negotiation skills. Staying organized and proactively managing timelines are essential for success in this fast-paced, detail-oriented role.

What is a regulatory medical writer?

A Regulatory Medical Writer prepares clinical and regulatory documents required for drug development and approval processes. They collaborate with scientists, clinicians, and regulatory teams to create clear, accurate, and compliant documents such as clinical study reports, investigator brochures, and regulatory submissions. Their work ensures that complex scientific data is communicated effectively to regulatory agencies like the FDA or EMA. Strong writing, analytical, and compliance knowledge are essential for this role.

Do regulatory medical writers make good money?

Regulatory medical writers typically earn competitive salaries that vary based on experience, education, and location. Entry-level positions may start around $70,000 annually, while experienced writers with specialized skills can earn over $120,000 or more, especially in the pharmaceutical or biotech industries. Certifications and proficiency with regulatory tools like eCTD can also influence earning potential.
What cities are hiring for Regulatory Medical Writer jobs? Cities with the most Regulatory Medical Writer job openings:
What are the most commonly searched types of Regulatory Medical Writer jobs? The most popular types of Regulatory Medical Writer jobs are:
What states have the most Regulatory Medical Writer jobs? States with the most job openings for Regulatory Medical Writer jobs include:
Infographic showing various Regulatory Medical Writer job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $80,364 per year, or $38.6 per hour.

Medical Writing Manager

micro1 AI

Kenosha, WI • Remote

$50 - $80/hr

Part-time

Posted 4 days ago


Job description

Role Title: Medical Writer / Clinical Document Author


Role Type: Contractor


Location: Remote


micro1 is engaging Medical Writers / Clinical Document Authors to participate in a customer’s project focused on developing advanced AI-assisted writing tools for clinical documentation. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required — your domain knowledge is what matters.


Scope of Work

  1. Author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs, and related clinical documents to inform AI tool development.
  2. Apply expert judgment to assess whether AI-generated content fulfills clinical template and structural requirements, including ICH E3 organization, section sequencing, cross-referencing, and appendix management.
  3. Evaluate scientific accuracy in narrative sections such as efficacy, safety summaries, discussion, and conclusions, distinguishing true scientific or interpretive errors from stylistic differences.
  4. Trace narrative claims to source records—tables, figures, listings, and protocols—to verify that all assertions are appropriately supported.
  5. Provide clear and structured written rationales for each assessment, enabling precise diagnosis and improvement of AI model behavior.
  6. Collaborate with project leads to refine evaluation frameworks and document best practices for clinical regulatory writing in the context of AI.


Preferred Qualifications

  1. Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.
  2. Direct experience independently authoring or leading the authoring of full Clinical Study Reports, beyond summaries or partial contributions.
  3. Fluency with ICH E3 and conventions for periodic safety documentation (ICH E2F, ICH E2C) and eCTD placement.
  4. Demonstrated ability to read and interpret TFLs and protocol documents, identifying where narrative diverges from source data.
  5. Exceptional written and verbal communication skills, especially in providing structured, actionable feedback on clinical content.
  6. Advanced degree in life sciences, pharmacy, or medicine (PhD, PharmD, MD, MSc), or equivalent depth of authoring experience.
  7. Experience across multiple clinical phases and therapeutic areas; oncology and haematology expertise is especially valued.


Join our customer's team and leverage your authoring expertise to help design the next generation of AI-assisted clinical documentation solutions. This high-bar role offers you the chance to shape how tomorrow's writing teams draft and review regulatory documents — through your expert input, judgment, and real-world experience.